Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL (NEUROTAX)

Phase II Multicentric, Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL

This study recommends the use of OnLife dietary supplement, which will be followed by a few day before the initiation of PACLITAXEL, for the prevention of PACLITAXEL induced neuropathy. OnLife will be continued one month after stopping chemotherapy.

This would limit the number of PACLITAXEL dose reductions and premature interruptions of this chemotherapy, thus potentially improving the results in terms of antitumor efficacy, while improving the quality of life of patients treated with weekly PACLITAXEL.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Placebo; Drug: OnLife®

Detailed Description

This study recommends the use of OnLife dietary supplement which will be followed by a few day before the initiation of PACLITAXEL for the prevention of PACLITAXEL induced neuropathy. OnLife will be continued one month after stopping chemotherapy. This would limit the number of PACLITAXEL dose reductions and premature interruptions of this cehemotherapy, thus potentially improving the results in terms of antitumor efficacy while improving the quality of life of patients treated with weekly PACLITAXEL.

Two treatment arms :

- ARM A : 20 patients included in the placebo arm (Standard chemotherapy with PACLITAXEL + placebo dietary supplement) ARM B : 40 patients included in the experimental arm (standard PACLITAXEL chemotherapy + OnLife® food supplement)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Didier MAYEUR, Doctor; Phone Number: +33 03 80 73 75 00; Email: dmayeur@cgfl.fr
• Study Contact Backup: Name: Emilie REDERSTORFF; Phone Number: +33 03 80 73 75 00; Email: erederstorff@cgfl.fr

Study Locations

• France
  • Dijon, France, 21000
    • Recruiting
    • Centre Georges François Leclerc
    • Contact: Didier MAYEUR, Dr; Email: dmayeur@cgfl.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Breast cancer patient with neo-adjuvant or adjuvant management, with an indication for weekly PACLITAXEL 80 mg/m² for 12 courses.
• Age ≥ 18 years
• Performans Status ≤ 3 according to Karnofsky and life expectancy greater than 6 months
• For patients of childbearing age, effective contraception while taking Onlife®/placebo.
• Patient able to swallow OnLife/placebo® tablets easily
• Patient able and willing to follow all study procedures (including the completion of numerous questionnaires) in accordance with the protocol
• Patient has understood, signed and dated the consent form
• Patient affiliated to the social security system

Exclusion Criteria:

• Patient previously started on PACLITAXEL
• Known allergy to any of the substances in the study product Onlife®/placebo (fish oil product)
• Diabetes
• Exogenous (Alcoholism)
• History of peripheral neuropathy at inclusion and/or presence of sensory and/or motor disorders due to other neurological diseases
• Pregnant or breastfeeding woman
• Other uncontrolled progressive pathologies
• Impossible or random follow-up
• Persons deprived of liberty or under guardianship (including curatorship)
• Inability to submit to the medical follow-up of the trial for geographical, social or psychological reasons.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Standard chemotherapy PACLITAXEL + placebo dietary supplement	Other: Placebo; It is administered for the duration of PACLITAXEL chemotherapy with the first administration performed 5 days before the first PACLITAXEL administration. Placebo will be continued for another 4 weeks after the last PACLITAXEL administration. One tablet in the morning and one in the evening daily
Experimental: OnLife®; Standard chemotherapy + OnLife® dietary supplement	Drug: OnLife®; It is administered for the duration of PACLITAXEL chemotherapy with the first administration performed 5 days before the first PACLITAXEL administration. The OnLife supplement will be continued for another 4 weeks after the last PACLITAXEL administration. One tablet in the morning and one in the evening daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropathies will be graded by the oncologist using the NCI-CTCAE version 5.0.	Neuropathies will be graded by the oncologist using the NCI-CTCAE version 5.0. during the consultation with the oncologist at 3 months. The AE graded from 1 to 5. Grade 1 is a better and grade 5 is a worst outcome.	At 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Neuropathic pain symptom inventory (NPSI) scores	Evaluation of Neuropathic pain symptom inventory scores by the questionnaire. The minimum value is 0 (no pain) and the maximum value is 10 (maximum pain)	At 12 weeks, 16 weeks, 6 months and 12 months
All peripheral neuropathies graded by the oncologist according to CTCAE V5.0	Assess the rate of grade ≥ 2 peripheral neuropathy by NCI-CTCAE V5.0 The AE graded from 2 to 5. Grade 2 is a better and grade 5 is a worst outcome.	Every 4 weeks for one year
Time to onset of grade ≥ 2 neuropathy.	Assess time to onset of grade ≥ 2 neuropathy by Kaplan-Meyer method The AE graded from 2 to 5. Grade 2 is a better and grade 5 is a worst outcome.	During 1 year
Number of toxicities attributable to OnLife® dietary supplement	Assess toxicities attributable to OnLife® dietary supplement by NCI-CTCAE V5.0	Every 4 weeks for one year
Number of participants with musculoskeletal and joint pain	Musculoskeletal and joint pain will be defined and graded according to the CTCAE v5.0 classification	At 12 weeks, 16 weeks 6 months and 12 months.
Compliance with the Onlife®/Placebo dietary supplement	Compliance with the Onlife®/Placebo dietary supplement will be assessed by the accounting for treatments returned by patients to the pharmacy.	16 weeks
Quality of life of participants	Quality of life will be assessed by the EORTC QLQ C30 self-questionnaires and its associated module Chemotherapy-Induced Peripheral Neuropathy (CIPN 20). The minimum value is 1 (no way) and the maximum value is 4 (a lot)	At baseline and then every 4 weeks for 4 months and then at 6 and 12 months.
The number and rate of women with at least one dose reduction due to peripheral neuropathy.	By NCI-CTCAE V5.0	During 1 year
Name of all concomitant treatments administered for neuropathy	By recording data in the eCRF for both arms	At 12 weeks, 16 weeks, 6 months and 12 months.
Evaluation of Overall Neuropathy Limitations Scale (ONLS) scores	Evaluation of ONLS scores by the questionnaires. The minimum value is 0 (better outcome) and the maximum value is 5 (worse outcome)	At 12 weeks, 16 weeks, 6 months and 12 months
Compliance with the Onlife®/Placebo dietary supplement	Compliance with the Onlife®/Placebo dietary supplement will be assessed by the Morisky questionnaire	16 weeks
The number and rate of women with at least one discontinuation of PACLITAXEL due to peripheral neuropathy.	By NCI-CTCAE V5.0	During 1 year

Collaborators and Investigators

• Sponsor: Centre Georges Francois Leclerc

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 2, 2023
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: breast; dietary supplement; Paclitaxel; neuropathy; OnLife
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Nervous System Diseases; Poisoning; Neurotoxicity Syndromes
• Other Study ID Numbers: 2022-A01940-43

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No